Events

Rappel de TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Invacare Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    61555
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1905-2012
  • Date de mise en oeuvre de l'événement
    2012-04-06
  • Date de publication de l'événement
    2012-06-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-05-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108412
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Wheelchair, powered - Product Code ITI
  • Cause
    Invacare corporation decided to recall the product because of a potential risk of fire and serious injury. the post fuse assemblies could potentially have a short between the positive ring terminal and the terminal battery bracket which would create an alternate current path around the fuse.
  • Action
    Invacare sent an "URGENT: RECALL INFORMATION" letter dated June 7, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. THe letters instructs customers to examine their inventory for the affected product and quarantine any product found. AProvider Response Form was enclosed for customers to complete and return via fax to 888-345-0289. Contact the firm at 888-641-9738 for assistance with this recall.

Device

TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair
  • Modèle / numéro de série
    TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, and FDX-MCG.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Puerto Rico and the countries of Australia, Germany, New Zealand.
  • Description du dispositif
    TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, FDX-MCG. Mrf. By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035. || Intended to provide mobility to a person restricted to a sitting position.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Adresse du fabricant
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-6248
  • Société-mère du fabricant (2017)
    Invacare Corporation
  • Source
    USFDA